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This study aims to test a new medical device, called the eyeWatch, used in filtering surgery for the treatment of glaucoma. This medical device has the following property: it allows better control of intraocular pressure in the initial postoperative phase by adjusting aqueous flow going through the device. The target criteria for the study are defined as: keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs; evaluating the number and type of postoperative complications. So far, this device has been already tested on 20 patients in Switzerland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eyeWatch device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eyeWatch system | Device | The eyeWatch device is composed of an AGDD, a control unit and a draining plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of serious adverse device events | Demonstration of safety. The number and type of serious adverse device event per patient will be measured. Results of biomicroscopy, gonioscopy, pachymetry visual field and endothelial count will be compared to baseline. | Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline |
| Effectiveness in reducing the intraocular pressure | Demonstration of the performance. The intraocular pressure (IOP in mmHg) will be measured at different time points to show the effective reduction compared to baseline. IOP reduced by ≥ 20% or IOP < 21 mmHg, and no IOP < 5 mmHg on two consecutive visits after 1 month (included) | Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Thomas' Hospital | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24557347 | Background | Villamarin A, Roy S, Bigler S, Stergiopulos N. A new adjustable glaucoma drainage device. Invest Ophthalmol Vis Sci. 2014 Mar 25;55(3):1848-52. doi: 10.1167/iovs.13-12626. |
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There is no plan
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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